Download Finadyne Solution - Veterinary Medicines Directorate

Revised: July 2012
AN: 01848/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Finadyne 50 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance :
% w/v
Flunixin
(as Flunixin Meglumine )
5.0
Excipients:
Phenol
(preservative)
0.50
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1
Target species
Cattle, horses and pigs
4.2
Indications for use, specifying the target species
In Cattle:
For the control of acute inflammation associated with respiratory disease.
Finadyne has also been shown to have some benefit in the treatment of
experimental acute bovine pulmonary emphysema (Fog Fever).
Finadyne Solution may be used as adjunctive therapy in the treatment of
acute mastitis.
In Horses:
For the alleviation of inflammation and pain associated with musculoskeletal disorders.
For the alleviation of visceral pain associated with colic in the horse.
In Pigs:
For use as an adjunctive therapy in the treatment of swine respiratory
diseases
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4.3
Contra-indications
Do not exceed the stated dose or the duration of treatment.
Use is contra-indicated in animals suffering from cardiac, hepatic or renal
disease, where there is the possibility of gastro-intestinal ulceration or
bleeding, or where there is hypersensitivity to the product.
Do not use the product within 48 hours before expected parturition in cows.
Do not administer to pregnant mares.
Do not administer to pregnant sows, gilts at mating and in breeding boars.
4.4
Special warning for each target species
Non-steroidal, anti-inflammatory drugs are not permitted under the rules of
Racing and under rules covering other competitive events.
The Royal College of Veterinary Surgeons has given advice to the
Veterinary Profession regarding the use of anti-inflammatory drugs in
competing horses. It states that “if a veterinarian recommends the
discontinuation of any such drug not less than eight days before racing, he
should feel sure that he has catered for all but the most exceptional case”.
Do not exceed the recommended dose or duration of treatment.
4.5
Special precautions for use
i.
Special precautions for use in animals
Avoid intra-arterial injection.
NSAIDS are known to have the potential to delay parturition through
a tocolytic effect by inhibiting prostaglandins that are important in
signalling the initiation of parturition. The use of the product in the
immediate post-partum period may interfere with uterine involution
and expulsion of foetal membranes resulting in retained placentae.
See also section 4.7.
Use in any animal less than 6 weeks of age or in aged animals may
involve additional risk. If such use cannot be avoided animals may
require a reduced dosage and careful clinical management.
Do not use in hypovolaemic animals except in the case of
endotoxaemia or septic shock.
It is preferable that NSAIDs which inhibit prostaglandin synthesis are
not administered to animals undergoing general anaesthesia until
fully recovered.
The cause of colic should be determined and treated with concurrent
therapy.
The product should not be used in piglets weighing less than 6 kg.
ii.
Special Precautions to be taken by the Person Administering the
Product to the Animal
Avoid contact with skin or eyes.
In case of skin contact, wash exposed area with water.
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In case of eye contact, wash eyes thoroughly with clean water and
seek medical advice.
Take care against accidental self injection.
Wash hands after use.
4.6
Adverse reactions (frequency and seriousness)
Flunixin meglumine is a non-steroidal anti-inflammatory drug (NSAID).
Untoward effects include gastro-intestinal irritation, ulceration and, in
dehydrated or hypovolaemic animals, potential for renal damage.
In pigs transient irritation may occur at the injection site, this resolves
spontaneously within 14 days.
4.7
Use during pregnancy, lactation or lay
The product may be used in pregnant and lactating cattle.
The product should only be administered within the first 36 hours postpartum following a benefit/risk assessment performed by the responsible
veterinarian and treated animals should be monitored for retained
placentae.
Do not use in pregnant mares or pregnant sows. Safety studies in pregnant
mares and pregnant sows have not been conducted.
4.8
Interaction with other medicinal products and other forms of
interaction
Do not administer other NSAIDs concurrently or within 24 hours of each
other.
Some NSAIDs may be highly bound to plasma proteins and compete with
other highly bound drugs which can lead to toxic effects.
Concurrent administration of potentially nephrotoxic drugs should be
avoided.
4.9
Amounts to be administered and administration route
Cattle
2ml per 45kg bodyweight (equivalent to 2.2mg flunixin per kg) administered
intravenously. Repeat as necessary at 24 hour intervals for up to 5
consecutive days.
Horses
By intravenous injection for musculo-skeletal disorders at the following rate:
1ml per 45kg bodyweight (1.1mg flunixin/kg) once daily for up to 5 days
according to clinical response.
By intravenous injection for colic at the following rate:
1ml per 45kg bodyweight (1.1 mg flunixin/kg) repeated once or twice if colic
recurs.
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For the treatment of endotoxaemia or septic shock associated with gastric
torsion and with other conditions in which the circulation of blood to the
gastro-intestinal tract is compromised: 0.25mg/kg every 6-8 hours, by
intravenous injection.
Pigs
2 ml per 45 kg bodyweight (equivalent to 2.2 mg flunixin/kg) once by
intramuscular injection, in the neck, in conjunction with appropriate
antimicrobial therapy. The injection volume should be limited to a maximum
of 5 ml per injection site.
An appropriately graduated syringe must be used to allow accurate
administration of the required dose volume. This is particularly important
when injecting small volumes.
When intramuscular injection is used, the dose should be divided between
two injection sites on either side of the neck.
In order to prevent excessive broaching of the rubber stopper, it is not
recommended that the stopper is broached more than 25 times.
4.10
Overdose (symptoms, emergency procedures, antidotes) if necessary
Overdosage studies in the target species have shown the product to be
well-tolerated. Flunixin meglumine is a non-steroidal anti-inflammatory drug.
Overdosage is associated with gastrointestinal toxicity. Concurrent use of
nephrotoxic drugs should be avoided.
4.11
Withdrawal period(s)
Animals must not be slaughtered for human consumption during treatment.
Cattle:
5 days from the last treatment.
Horses:
7 days from the last treatment.
Pigs:
22 days from the last treatment.
Milk for human consumption must not be taken during treatment. Milk for
human consumption may only be taken from cattle after 24 hours from the
last treatment.
5.
PHARMACOLOGICAL PROPERTIES
Flunixin meglumine is a potent, non-steroidal, non-narcotic analgesic with
anti-inflammatory, anti-endotoxic and anti-pyretic activities.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Phenol
Diethanolamine
Disodium Edetate dihydrate
Sodium Formaldehyde sulfoxylate dihydrate
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Propylene Glycol
Hydrochloric acid 2.0N
Water for injection
6.2
Incompatibilities
Do not administer other NSAIDs concurrently or within 24 hours of each
other.
Some NSAIDs may be highly bound to plasma proteins and compete with
other highly bound drugs which can lead to toxic effects.
Concurrent administration of potential nephrotoxic drugs should be avoided.
6.3
Shelf-life
3 years
Following withdrawal of the first dose, use within 28 days.
Discard unused material.
6.4
Special Precautions for Storage
Do not store above 25°C.
Do not freeze.
6.5
Nature and composition of immediate packaging
Pack Sizes: 50 ml and 100 ml vials.
Containers: Clear Type I glass vials, molded.
Closures:
Chlorobutyl rubber stopper with aluminium cap - one piece
with tear-off centre.
6.6
Special Precautions for the Disposal of Unused Product or Waste
Material
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance
with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Intervet UK Ltd
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8.
MARKETING AUTHORISATION NUMBER
Vm
01708/4582
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9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 27/08/1987
Date of last renewal:
27/08/2007
10.
DATE OF LAST REVISION
Date: July 2012
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable
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